Nutrition-support-team Based Intervention in Patients With Advanced Gastrointestinal Cancer (NSTBIPAGC)

Effect of Nutrition-support-team Based Intervention on Nutritional Status, Chemotherapy Tolerance and Prognosis in Patients With Advanced Gastrointestinal Cancer

The research studies patients with advanced gastrointestinal cancer who receive chemotherapy in the medical oncology department of the First Affiliated Hospital of Xian Jiaotong University. All patients receive the nutritional risk assessment by the nutritional support team first, and patients with nutritional risk or malnutrition are randomly assigned to the study group and the control group. The study group receive nutritional intervention from the nutritional support team during the period of chemotherapy, while the control group receive routine nutritional support from their clinicians. In the control group, nurses execute the doctors' advice on nutrition, and the nutrition support team does not actively communicate with doctors about the nutritional risk of patients or interfere with it. The baseline characteristics, chemotherapy efficacy, adverse events and prognosis are collected in both groups. At last, data are analyzed to clarify the nutritional status and related factors of patients with advanced gastrointestinal cancer in our hospital, and most important to explore the effect of nutrition-support-team intervention on nutritional status, chemotherapy tolerance and prognosis of patients with advanced gastrointestinal cancer.

Study Overview

• Status: Unknown
• Conditions: Malnutrition; Gastrointestinal Cancer; Nutrition Aspect of Cancer
• Intervention / Treatment: Other: NST group

Detailed Description

Baseline data include age, gender, pain, sleep condition, family care, tumor type, tumor stage, combined disease, chemotherapy regimen and concomitant medication.

Nutritional risk assessments are performed by the nutrition support team just after enrollment, every two cycles of chemotherapy and at the end of the study. The adverse events of chemotherapy are collected and recorded at the end of each cycle. CT or MRI is performed to evaluate efficacy of chemotherapy every two treatment cycles. Patient after one treatment cycle can receive CT or MRI in advance if the clinical condition is worsening.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital of Xian Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• advanced (recurrent or metastatic) gastrointestinal malignancies confirmed by pathology, plan to be treated with chemotherapy
• the expected life period is more than 3 months
• did not receive chemotherapy, radiotherapy, molecular targeted therapy or surgery in the last 4 weeks
• has been recovered from the acute toxicity of previous treatment (if patient received surgery, the wound must have completely healed)
• at least one measurable lesion according to RECIST 1.1 edition (the measurable lesion has not received radiotherapy)
• normal function of main organs:Blood routine examination needs to be met: Hb≥90g/L (without blood transfusions within 14 days); ANC≥1.5×109/L; PLT≥80×109/LBiochemical examination should conform to the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5×ULN (ALT and AST≤5×ULN, in case of liver metastasis); Serum creatinine ≤1×ULN, creatinine clearance rate >50ml/min (Cockcroft-Gault formula)
• volunteer to participate in the study, sign the informed consent, and cooperate with good compliance

Exclusion Criteria:

• pregnancy or lactation
• having a long-term unhealed wound, traumatic or pathological fracture
• urinary protein > 2+ or 24 hour urinary protein >1.0g
• suffering from mental illness
• with hypertension and fail to get good control through antihypertensive medication (systolic pressure >140mmHg and/or diastolic pressure >90mmHg)
• serious diabetes, heart disease (including but not limited to myocardial ischemia, myocardial infarction, cardiac insufficiency, congestive heart failure), thrombotic diseases (including but not limited to cerebral hemorrhage, deep venous thrombosis and pulmonary embolism)
• long-term use of steroid for other medical reasons
• with diseases that may increasing the underlying research risk judged by researchers
• having a bleeding tendency or a great worry of gastrointestinal bleeding
• with infection requiring antibiotic treatment
• history of immunodeficiency, including HIV positive, organ transplantation and other acquired/congenital immunodeficiency disorders
• patients with Hepatitis B(except inactive carrier) or Hepatitis C
• took part in other clinical studies or is involved in other research projects at present

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NST group; Nutrition support team gives the dietary supplement or other nutritional support during the period of chemotherapy	Other: NST group; Nutrition-support-team based intervention on nutrition, including dietary supplement, parenteral nutrient solutions and patient education
NO_INTERVENTION: routine group; clinicians decide whether to give and how to give the dietary supplement and other nutritional support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nutritional status	effect of nutrition-support-team intervention on nutritional status, nutritional risk assessments	From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chemo-related adverse events	amount of chemo-related adverse events	From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months
total chemotherapy cycles	amount of total cycles of chemotherapy	From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months
progression-free survival	the survival time of patient without progression	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months
adverse events	Amount of adverse events related to nutritional intervention	From time of randomization to one week of the ends of nutritional intervention，assessed up to 7 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Director: Lingxiao Zhang, doctor, First Affiliated Hospital of Xian Jiaotong University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 20, 2018
• Primary Completion (ANTICIPATED): August 20, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (ACTUAL): August 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 19, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Nutrition Disorders; Gastrointestinal Neoplasms; Malnutrition
• Other Study ID Numbers: XJTU1AF-CRF-2017-027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No